MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
EU – MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
More from Clinical EvaluationMore posts in Clinical Evaluation »
- EU – Guidance – Clinical evaluation assessment report template
- EU – MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
- EU – MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
- Medical Device Clinical Evaluation Tip 1 – Use of NOT Boolean operator in search strategies
- IMDRF Final Documents – Clinical Evidence, Clinical Evaluation and Clinical Investigation
More from GuidanceMore posts in Guidance »
- EU – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- UU – Final guidance – Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
- US Final Guidance – Bone Anchors – Premarket Notification (510(k)) Submissions
- FDA Issues Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
More from MDCG - Medical Devices Coordination GroupMore posts in MDCG - Medical Devices Coordination Group »
- EU – MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
- EU – MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
- EU – Ongoing Guidance development within MDCG Subgroups
- EU – MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
- EU – MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
More from Medical Device Regulation MDRMore posts in Medical Device Regulation MDR »
- EU – Guidance – Clinical evaluation assessment report template
- EU – Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
- UK – MHRA – Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
- EU – COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
- EU – Mandate M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the CEN and the CENELEC in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
More from Notified BodyMore posts in Notified Body »
- EU – Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
- EU – New notified body designated under the MDR – NB 2862 -Intertek Medical Notified Body AB
- EU – Team-NB – Contacts to allow the check of the validity of the CE certificates
- EU – New notified body designated under the MDR – NB 0483 – MDC MEDICAL DEVICE CERTIFICATION GMBH
- EU – MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
Be First to Comment